DR Systems Unity PACS software recall
DR Systems Unity PACS software, now known as Merge Unity PACS
Why was DR Systems Unity PACS software recalled?
Reports were missing demographic header information when they were faxed to referring physicians.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Version 11.0
- Product
- DR Systems Unity PACS software, now known as Merge Unity PACS
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 9 sites potentially have the affected version
- Distribution
- US Distribution was made to medical facilities in CA, MT, PA, and TX. There was no foreign/military/government distribution.
- Recall date
- March 15, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)